AdClin Reporting SystemTM

01 Navigator / 02 Table Production Framework / 03 Report Builder

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Streamlining the process from

programming and statistics to medical writing

AdClin Reporting SystemTM software has been carefully designed to allow programmers, statisticians,

medical writers and physicians to integrate their work and to stay in tune with their business objectives.

Freeingusers from constraints

due to database structures and underlying tools

Whatever the database structure and the complexity of required reporting tables, AdClin Reporting SystemTM

frees users to only spend their time on the true semantic, value-added part of their job.

Matchingthe requirements of various users

in the organization, thanks to its modular architecture:

> AdClin NavigatorTM, to instantly view and navigate SAS®

clinical databases, making information just a click away.

> AdClin Table Production FrameworkTM, a unique SAS®-based productivity framework that

produces 100% of summary tables and data listings.

> AdClin Report BuilderTM, an innovative tool automating the integration of tables and listings into Word documents.

AdClin Reporting SystemTM A new generation software tool maximizing the ef ficiency and security of clinical data reporting.

AdClin Reporting SystemTM is based on an innovative approach not boundto underlying tools limitations, designed to match the whole process for producingclinical reports. The results are great improvements of productivity,quality and validation, allowing users to stay focused on their business objectives.

Easy Data Access: AdClin NavigatorTM provides instant and comfortable data access, while AdClin Table Production FrameworkTM allows generating easily any kind of table or listing, that are then easily integrated into reports thanks to AdClin Report BuilderTM.

Increased Productivity: Lengthy manual operations are reduced to a few mouse clicks, and daunting programs turned into concise and safe macro invocations.

Better Validation: Data otherwise concealed in SAS® databases can be made availableto all professionals involved in the clinical trial, regardless of their technical skills, and shorter programs make validation much faster.

Easy Integration: All modules integrate seamlessly into any existing process, can be rolled out extremely quickly, and are immediately usable and productive.

CRF

Data Updates Lab. Data, Holter...

Diaries Data &ResultsStudy Data Analysis Data

Derivations &Reshaping

SatisticalAnalysis & Data

Reporting

Integration & Formatting

Internet

Table Production Framework Report Builder Data Entr y & Cleaning Clinical Programming & Statistical Analysis Medical Writing

AdClin Navigator

Final Report

01 AdClin

AdClin Reporting SystemTM

Adverse events are only a click away from

related concomitant medications

AdClin Navigator TM

AdClin NavigatorTM is a point-and-click, user-friendly tool to navigate clinical databases for both non-technical users and SAS® experts.

Thanks to the use of industry-standard, well known, feature-rich Microsoft Excel® interface, AdClin NavigatorTM is the tool of choice to easily access and navigate clinical data in various situations:

PhysiciansClinical data concealed in SAS® databases becomes accessible and readable by all the non-technical staf f in a few clicks, avoiding lengthy and inflexible printed data listings.

Blind ReviewsAttached to a video projector, AdClin NavigatorTM makes blind reviews more attractive and consistent: instant access to readable data allows rapid and easy exchange of information.

ProgrammingInstant access to datasets, variables and formats, easy filtering give optimal understanding of the data and reduces the risk of programming errors.

Quality ControlData from a third-party can be reviewed and validated very easily, tracking related data in a few mouse clicks.

Requirements: Microsoft Excel® version 2000 or later. (To expor t the data, SAS® version 8.2 or later.)

02

AdClin Reporting SystemTM

Typical volume of code

AdClin Table Production Framework TM

A unique productivity framework based on SAS®, allowing clinical programmers to easily, securely and ef fectively produce tables in the exact way they are needed.

AdClin Table Production FrameworkTM inherited from AdClin’s advanced vision and in-depth understanding of clinical business process and requirements. It frees programmers and statisticians from SAS® limitations, and helps them stay focused on their business objectives.

Key benefitsProductive and Secure: because it allows a dramatic decrease of the amount of code needed to produce listings and tables, programs are both written and validated much more quickly.

Exhaustive Scope, Environment-Neutral: it allows producing any kind of data listing and summary table, regardless of input data structure, output layout, and customer reporting process.

Usable and Evolving: its functional and technical design makes it quick to deploy, immediately usable, and at the same time open to the most various improvements, and to the evolution of standards (e.g., XML).

Base SAS®

AdClin®

03 AdClin

AdClin Table Production Framework TM

AdClin Reporting SystemTM

All listings and tables available for review using an Internet browser

Table presentation is controlled outside of programs to easily match corporate standards

Unique FeaturesIndependence versus the input data structure: changing from “ver tical” to “horizontal” input shape or vice-versa just involves tuning the notation used to access the data, not preprocessing it.

Repor ting data from various datasets together requires no more than specifying where the data should be taken (automatic and safe “merge” of datasets).

Ability to include any kind of statistical result computed by the user together with or in lieu of the statistics and results computed by the product.

Ability to compute any kind of percentage (any kind of denominator) without any preprocessing.

Requirements:SAS® version 8.2 or later, BASE and STAT modules

03 AdClin

AdClin Reporting SystemTM

Tedious manual pasting of tables in clinical study reports is over

AdClin Report Builder TM

AdClin Report BuilderTM allows instant inclusion and formatting of any number of tables and listings into submission-ready documents.

AdClin Report BuilderTM has been designed to dramatically reduce the workload associated with including tables and listings into clinical study repor ts.

Fully automated, it provides state-of-the ar t quality assurance, as results need not be manually reformatted (or even worse, retyped) into documents.

Thanks to its simple, point-and-click inter face, AdClin Repor t BuilderTM brings an unmatched comfor t of use for creating high quality documents.

Unique FeaturesMass integration of all tables and listings in Word documents, at their final location, with one mouse click.

Easy switch to landscape of tables or listings that do not fit in por trait.

Automatic and fully customizable pagination of tables and listings.

Advanced features such as automatic bookmarking for cross-references or instant renumbering.

Requirements:SAS® version 8.2 or later, BASE and STAT modules

AdClin®/ Smart Clinical SoftwareTM

Since 1999, AdClin has provided the pharmaceutical industry with innovativeclinical data software products and services which dramatically increase both productivity and compliance to 21 CFR Part 11, thus safely shortening time to market.

Addressing the Needs of Pharmaceutical Companies and CROs

AdClin was founded to provide answers in identified areas where there is roomfor significant improvements through adequate productivity tools.To date, AdClin has been providing two innovative clinical data software product suites matchingthe business needs of renowned pharmaceutical companies and CROs:

> AdClin Reporting SystemTM, streamlining the overall clinical data reporting process.> AdClin Study NormalizerTM, easily converting multiple databases to CDISC-compliant format.

Key References

Sanofi-Aventis, Fournier Pharma, Orphan Europe, Sanofi-Pasteur, Centelion, Novartis, MDS Pharma Services, MAPI Group, Guerbet Group, L’Oréal.

ContactsAdClin SA - 11, rue des Petites Ecuries / F-75010 Paris, FrancePhone +33 1 56 82 03 00 - Fax: +33 1 56 82 03 09http://www.adclin.com / Email: sales@adclin.comAll trademarks used are proper ties of AdClin® or their respective owners.

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